Integra LifeSciences recalls Talar Dome Total Ankle Prosthesis (Flat Cut, Size 2, Right) due to incorrect metal coating labeling on implant labels and instructions. Affected patients should contact for details.
The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metallic coating material symbol on the metallic implant labels (box and inner pouch) and IFU
Integra LifeSciences is recalling a specific type of ankle prosthesis because the labels and instructions list the wrong metal coating material. This labeling error could lead to confusion about the implant's composition, but it does not pose an immediate safety risk to users.
The recall involves incorrect labeling of the metal coating material on the implant's box and inner pouch labels, as well as the instructions for use. This error could cause confusion about the implant's composition but does not involve a physical hazard that could cause injury during normal use.
Patients who own the recalled Talar Dome Total Ankle Prosthesis (Flat Cut, Size : 2, Right) with Product No. LJU812T are affected. Those with this specific implant model are most at risk due to potential labeling confusion.
Check for the product name 'Talar Dome Total Ankle Prosthesis', flat cut, size 2, right, and product number LJU812T. The recall covers specific serial numbers: 180077, 182902, and 185086.
Reach out to Integra LifeSciences for details about the recall and next steps.
No, the recall is for labeling errors that could cause confusion about the metal coating material but does not pose an immediate safety risk.
Contact Integra LifeSciences directly for details about the recall and next steps.
Check for the product name 'Talar Dome Total Ankle Prosthesis', flat cut, size 2, right, and product number LJU812T with serial numbers 180077, 182902, or 185086.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-1166-2019 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-1166-2019 from Integra LifeSciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
